FDAFDA · Food and drugs·Recall number Z-2872-2017
BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.
Published August 16, 2017 · Recall initiated: June 2, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- C.R. Bard, Inc.
- Distributor
- US Nationwide in the states of CA, CO, FL, IL, IN, LA, MN, MO, NC, NJ, NY, OH, OK, PA, TX, WY, including PR.
- Lot
- Product Code 151919; Lot No. NGAS4058
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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